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Monday, March 11, 2019
| Time | Event | Location |
|---|---|---|
| 5:00-7:00 p.m. | Registration | Conference Registration Desk |
| 6:00-8:00 p.m. | Networking Reception | Hill Atrium |
Tuesday, March 12, 2019
| Time | Event | Location/Speaker |
|---|---|---|
| 7:00-8:30 a.m. | Breakfast Buffet | Magnolia Room |
| 7:30-8:30 a.m. | Late Registration | Conference Registration Desk |
| MORNING SESSION - Mahler Auditorium | ||
| 8:30-8:45 a.m. | Welcome and Orientation | Dean Kelly M. Smith & Michael Bartlett , University of Georgia |
| 8:45-9:30 a.m. | Update from the Office of Regulatory Affairs | Alonza Cruse, FDA ORA |
| 9:30-9:45 a.m. | Q&A Panel | |
| 9:45-10:15 a.m. | Networking Break | Hill Atrium |
| 10:15-11:00 a.m. | Assuring GXP Data Integrity – Cybersecurity | Anil Sawant, Merck |
| 11:00-11:45 a.m. | Compliance Trends and Issues for the Generic Industry | Dan Barreto, Teva |
| 11:45 a.m. - 12:00 p.m. | Q&A Panel | |
| 12:00-1:00 p.m. | Networking Lunch | Magnolia Room |
| AFTERNOON SESSION - Mahler Auditorium | ||
| 1:00-1:45 p.m. | What Practical Impact Will Brexit Have? A view from pharma companies | Tor Gråberg, AstraZeneca |
| 1:45-2:30 p.m. | Update from PDA Task Force on Data Integrity | Ronald Tetzlaff, Parexel |
| 2:30-2:45 p.m. | Q&A Panel | |
| 2:45-3:15 p.m. | Networking Break | Hill Atrium |
| 3:15-4:00 p.m. | Quality Metrics and Operational Excellence: Bringing together what belongs together — Insights from a Decade of Research | Thomas Friedli, University of St. Gallen |
| 4:00-4:45 p.m. | Controlling Human Error in the Manufacturing Floor | Ginette Collazo, Human Error Solutions |
| 4:45-5:00 p.m. | Q&A Panel | |
| 6:30-8:30 p.m. | Dinner "Universal Influenza Vaccines" | Magnolia Room Ted Ross, University of Georgia |
Wednesday, March 13, 2019
| Time | Event | Location/Speaker |
|---|---|---|
| 7:00-8:15 a.m. | Breakfast Buffet | Magnolia Room |
| MORNING SESSION - Mahler Auditorium | ||
| 8:15-9:00 a.m. | Making Better Decisions in a Regulated Environment — Cognitive Bias and Critical Thinking | William Mestrandrea, Celgene |
| 9:00-9:45 a.m. | Virtual Manufacturing Challenges | Ted Wheeler, Aerie Pharmaceuticals |
| 9:45-10:00 a.m. | Q&A Panel | |
| 10:00-10:30 a.m. | Networking Break | Hill Atrium |
| 10:30-11:15 a.m. | Case Studies from GMP Inspections | Ileana Barreto-Pettit, FDA ORA |
| 11:15 a.m. - 12:00 p.m. | Preparing for FDA Pre-Approval Inspections | Johnetta Walters, FDA ORA |
| 12:00-12:15 p.m. | Q&A Panel | |
| 12:15-1:15 p.m. | Networking Lunch | Magnolia Room |
| AFTERNOON SESSION - Mahler Auditorium | ||
| 1:15-2:00 p.m. | Complaint Handling: How Far Should You Go? | Jennifer Ahearn, Engineering Systems |
| 2:00-2:45 p.m. | Medical Product Communications | Alan Minsk, Arnall Golden Gregory LLP |
| 2:45-3:00 p.m. | Q&A Panel | |
| 3:00-3:30 p.m. | Networking Break | Hill Atrium |
| 3:30-4:15 p.m. | QRM in PQS: The Future Shape | Eva Urban, Celgene, PDA Quality Group |
| 4:15-5:00 p.m. | Health Canada Inspection Trends and Case Studies | Anthony Lostracco, Health Canada |
| 5:00-5:15 p.m. | Q&A Panel | |
| 5:15-6:45 p.m. | Networking Reception, joined by UGA graduate students and postdocs | Hill Atrium |
| Enjoy dinner in Athens! See our Local Recommendations for inspiration for your night on the town. |
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Thursday, March 14, 2019
| Time | Event | Location/Speaker |
|---|---|---|
| 7:00-8:15 a.m. | Breakfast Buffet | Magnolia Room |
| MORNING SESSION - Mahler Auditorium | ||
| 8:15-9:00 a.m. | FDA Oversight of Drug Compounding | Hidee Molina, FDA CDER |
| 9:00-9:45 a.m. | Cell and Gene Therapy Quality Considerations | Vivianne Arencibia, QxP |
| 9:45-10:00 a.m. | Q&A Panel | |
| 10:00-10:30 a.m. | Networking Break | Hill Atrium |
| 10:30-11:15 a.m. | Elemental Impurities | Melissa Figgins, QxP |
| 11:15 a.m. - 12:00 p.m. | Ingredient Supplier Qualification | Marie Mathews, FDA CDER |
| 12:00-12:15 p.m. | Q&A Panel | |
| 12:15 p.m. | Conference Adjournment | |
| POST-CONFERENCE TUTORIAL: Room R (Second Floor) Session Coordinator: Trina von Waldner |
||
| 12:15-1:00 p.m. | Luncheon for Post-Conference Tutorial Participants | Magnolia Room |
| 1:00-2:30 p.m. | Trend Analysis and CAPA Verification | Jennifer Ahearn, Engineering Systems |
| 2:30-2:45 p.m. | Networking Break | Kellogg Concourse |
| 2:45-4:00 p.m. | Trend Analysis and CAPA Verification (continued) | Bob Wittorf, Merck |
| 4:00 p.m. | Post-Conference Adjournment | |
| Continuing Education (CE) credit available through this tutorial only. | ||